MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE SPACER BLOCK; ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS

Catalog Number 254401014

Device Problems Material Twisted/Bent (2981); Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

When the doctor was using the attune spacer block the i noticed one of the springs had become loose and was nearly falling off.Item needs to be replaced was surgery delayed due to the reported event? no, was procedure successfully completed? yes, patient status/ outcome / consequences: no.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: added: evaluation codes.Product complaint # (b)(4).Investigation summary: the 254401014 spacer block associated with the reported event was not returned for evaluation.Review of a provided photograph reveals one of the balseals is damaged and remains attached to the post.Two photographs of the complaint subject device were provided for review.One photograph shows the balseal damaged and still attached to the post.The second photograph shows the product/lot markings on the device and does not exhibit the damaged balseal.Dva-104585-dver30 shows that the shim and articulation surface (which uses a similar balseal connection) do not assemble as intended before the balseal breaks or disassociates from the post.This allows the user to see significant damage before the balseal disassociates from the post.Any damage too minor to prevent assembly would be picked up during cleaning and sterilization.If failure does occur during surgery, the risk of a part being left in the patient is minimal as the device must be assembled outside the joint space where the failure can be readily identified.The failure may result in an inability to use the spacer block, leading to the flexion and extension gaps being incorrectly sized.Dva-107785-fde dfmea lines 2 and 12 consider damage to the spacer block resulting in extension and flexion gaps being incorrectly sized and finds this as a broadly acceptable risk (bar) as ""the surgical workflow requires the insert thickness is checked during trialing and even at implantation, if the surgeon feels the joint is lax, he is able to increase the thickness of the insert."" the investigation could not draw any conclusions about the root cause of the damaged balseal without the device to examine.The q4 2017 pms report (103463554) identifies no safety signals and concludes no follow up actions are required for the attune spacer block.Complaint trends will be monitored by post market surveillance through sep-419.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE SPACER BLOCK
• Type of Device: ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8478860
• MDR Text Key: 140786744
• Report Number: 1818910-2019-89541
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295395379
• UDI-Public: 10603295395379
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254401014
• Device Lot Number: BFA0VPL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1